Validating the Digital Virginia Tech Carilion Cognitive Examination (VTC-Cog)

Validating the Digital Virginia Tech Carilion Cognitive Examination - A Unique Tool for Cognitive Assessment

Currently, cognitive screening is performed in-person after the individual expresses symptoms or it is noticed by someone close to them and are largely done in clinical settings. The digital Virginia Tech Carilion Cognitive Examination (VTC-Cog) utilizes smart devices and allows for the early establishment of an individual's cognitive baseline. VTC-Cog has been designed to test all major aspects of cognition, as currently assessed using the Montreal Cognitive Assessment (MoCA) and Mini-Mental Status Examination (MMSE) but on a digital platform. The VTC-Cog allows for standardized scoring with no clinician bias and provides a clinician report that breaks down distinct changes in different areas of cognition (executive, visuospatial, memory, etc.) in order to refine clinician analysis.

Study Overview

• Status: Withdrawn
• Conditions: Cognitive Change
• Intervention / Treatment: Device: The Digital Virginia Tech Carilion Cognitive Examination

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants must be 50-80 years old with no diagnosis of dementia who speak English, have no acute mental health concerns, and have a Carilion Clinic medical provider.

Description

Inclusion Criteria:

• Age 50-80 years
• No current diagnosis of dementia
• Current stable mental health
• English speaker
• Carilion Clinic Medical Provider

Exclusion Criteria:

• <50 years old or >80 years old
• Current diagnosis of dementia
• Unstable mental health
• Non-English speaker
• Medical provider outside the Carilion Clinic system

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Test Group; Reported mild cognitive deficits	Device: The Digital Virginia Tech Carilion Cognitive Examination; Completion of a newly developed digital cognitive screen
Control Group; No cognitive deficits	Device: The Digital Virginia Tech Carilion Cognitive Examination; Completion of a newly developed digital cognitive screen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Validation of the Digital Virginia Tech Carilion Cognitive Examination against the Montreal Cognitive Assessment	18-24 months

Collaborators and Investigators

• Sponsor: Carilion Clinic
• Collaborators: Digitally Enhanced Screening Applications
• Investigators: Principal Investigator: Azziza Bankole, MD, Physician

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): August 10, 2020
• Last Update Submitted That Met QC Criteria: August 6, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: VTC-Cog 19-554

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes